FDA.reportPublic FDA data

Bacitracin Zinc Ointment, USP

Manufacturer
Aidarex Pharmaceuticals LLC
Effective date
2012-09-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:33:01

Label at a glance#

ProductBacitracin Zinc
Active ingredientBACITRACIN ZINC
Label structure14 sections

Indications and uses

Helps prevent infection in minor cuts scrapes burns

Dosage and administration

clean affected area apply a small amount (equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

(in each gram)

Bacitracin zinc, USP 500 units

PURPOSE

OTC - PURPOSE SECTION

First aid antibiotic

USES

INDICATIONS & USAGE SECTION

Helps prevent infection in

  • minor cuts
  • scrapes
  • burns

WARNINGS

WARNINGS SECTION

For external use only

Allergy alert:

  • do not use if allergic to any of the ingredients

DO NOT USE

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body

ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • do not use longer than 1 week unless directed by a doctor

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

  • condition persists or gets worse
  • a rash or other allergic reaction develops

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • clean affected area
  • apply a small amount (equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • Store at room temperature 59°-77°F (15°-25°C).

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

White petrolatum

QUESTIONS?

OTC - QUESTIONS SECTION

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Repackaged By:
Aidarex Pharmaceuticals, LLC
Corona, CA 92880

NDC 33261-707-01

Bacitracin Zinc Ointment, USP

First Aid Antibiotic Ointment

Net WT 1 OZ (28 g)

11051210E1                VC110188

Image Label
Image Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN1
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD1
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-707-562020-01-31C16284748780-19d75b9d0-2ea8-f424-e053-dadaa90a57ceBacitracin Zinc Ointment, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-707-01Bacitracin Zinc28 g in 1 TUBEOINTMENT281
33261-707-56Bacitracin Zinc1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-707BACITRACIN ZINC OINTMENT [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20120912_aee808f9-e759-4129-9661-29c2a3bd9a30.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-707-01GM - Gram33261-7073548a7fc-29b4-489d-8f6c-2dfb1665622e12015-10-02
0472-1105-34GM - Gram0472-1105db8fcb8a-f27b-4101-8155-ab75e3d44fec12013-02-13
0472-1105-56GM - Gram0472-11052db5cf61-42cf-49e4-9bb3-9b667753b06a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ES1
BACITRACINACTIVE MOIETY58H6RWO52I1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
33261-70733261-707-01, 33261-707-56
0472-1105

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
BACITRACIN ZINC89Y4M234ESACTIB
PETROLATUM4T6H12BN9UIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a9c631b4-b783-4a4b-9b9e-f79bb60a7437aee808f9-e759-4129-9661-29c2a3bd9a302012-09-10WarningsExact identifier
spl id: a9c631b4-b783-4a4b-9b9e-f79bb60a7437
spl set id: aee808f9-e759-4129-9661-29c2a3bd9a30

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.